Pain Clinical Trial
Official title:
Clinical Protocol for a Multiple Dose Randomized, Double-Blind, Placebo Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Bunionectomy Surgery
| Verified date | May 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.
| Status | Completed |
| Enrollment | 450 |
| Est. completion date | February 2003 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block) - Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm - Patients with a baseline pain intensity (categorical) of moderate or severe Exclusion Criteria: - Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone - Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia - Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space - Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids - Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Addison | Illinois |
| United States | Pfizer Investigational Site | Altoona | Pennsylvania |
| United States | Pfizer Investigational Site | Altoona | Pennsylvania |
| United States | Pfizer Investigational Site | Annapolis | Maryland |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austintown | Ohio |
| United States | Pfizer Investigational Site | Bismarck | North Dakota |
| United States | Pfizer Investigational Site | Canfield | Ohio |
| United States | Pfizer Investigational Site | Chandler | Arizona |
| United States | Pfizer Investigational Site | Chester | Maryland |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Cooper City | Florida |
| United States | Pfizer Investigational Site | Cutler Ridge | Florida |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Elk Grove Village | Illinois |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Fort Lauderdale | Florida |
| United States | Pfizer Investigational Site | Ft. Lauderdale | Florida |
| United States | Pfizer Investigational Site | Ft. Lauderdale | Florida |
| United States | Pfizer Investigational Site | Glendale | Arizona |
| United States | Pfizer Investigational Site | Glendale | Arizona |
| United States | Pfizer Investigational Site | Greer | South Carolina |
| United States | Pfizer Investigational Site | Hallandale | Florida |
| United States | Pfizer Investigational Site | Havertown | Pennsylvania |
| United States | Pfizer Investigational Site | Holladay | Utah |
| United States | Pfizer Investigational Site | Hollywood | Florida |
| United States | Pfizer Investigational Site | Hollywood | Florida |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Layton | Utah |
| United States | Pfizer Investigational Site | Media | Pennsylvania |
| United States | Pfizer Investigational Site | Mesa | Arizona |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Milford | Connecticut |
| United States | Pfizer Investigational Site | National City | California |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New Haven | Connecticut |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | New Port Richey | Florida |
| United States | Pfizer Investigational Site | New Port Richey | Florida |
| United States | Pfizer Investigational Site | New Port Richey | Florida |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Pembroke Pines | Florida |
| United States | Pfizer Investigational Site | Pembroke Pines | Florida |
| United States | Pfizer Investigational Site | Peoria | Illinois |
| United States | Pfizer Investigational Site | Peoria | Illinois |
| United States | Pfizer Investigational Site | Peoria | Illinois |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Port Richey | Florida |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Provo | Utah |
| United States | Pfizer Investigational Site | Reading | Pennsylvania |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Sandy | Utah |
| United States | Pfizer Investigational Site | South Miami | Florida |
| United States | Pfizer Investigational Site | Spring Hill | Florida |
| United States | Pfizer Investigational Site | St. George | Utah |
| United States | Pfizer Investigational Site | State College | Pennsylvania |
| United States | Pfizer Investigational Site | Tacoma | Washington |
| United States | Pfizer Investigational Site | Upland | Pennsylvania |
| United States | Pfizer Investigational Site | Wyomissig | Pennsylvania |
| United States | Pfizer Investigational Site | Youngstown | Ohio |
| United States | Pfizer Investigational Site | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient's Global Evaluation of Study Medication | Day 2 and Day 3 | No | |
| Primary | Summed Pain Intensity (SPI) (categorical) through 24 hours | Day 2 and Day 3 | No | |
| Secondary | Health Outcomes Post-Discharge Recovery Experience | Days 2 to 5 | No | |
| Secondary | adverse events | continuous | Yes | |
| Secondary | Time to first dose of rescue medication (rescue analgesic medication) | Days 2 to 5 | No | |
| Secondary | SPI 24 (categorical) | Day 4 and Day 5 | No | |
| Secondary | Time-specific Pain Intensity (PI) (categorical) | Days 2 to 5 | No | |
| Secondary | SPI 24 (Visual Analog Scale [VAS]) | Days 2 to 5 | No | |
| Secondary | Time-specific PI (VAS) | Days 2 to 5 | No | |
| Secondary | Patient's Global Evaluation of Study Medication | Day 4 and Day 5 | No | |
| Secondary | Percent of patients who took rescue medication (rescue analgesic medication) | Days 2 to 5 | No | |
| Secondary | Worst Pain Intensity (derived from the Modified BPI-Short Form) | Days 2 to 5 | No | |
| Secondary | Time between doses of study medication | Days 2 to 5 | No | |
| Secondary | Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form) | Days 2 to 5 | No | |
| Secondary | Symptom Distress Questionnaire | Days 2 to 5 | No | |
| Secondary | Average Pain Intensity (derived from the Modified BPI-Short Form) | Days 2 to 5 | No | |
| Secondary | Amount of rescue medication (rescue analgesic medication) taken | Days 2 to 5 | No |
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